WASHINGTON, June 5, 2024 (BSS/AFP) - A panel of US health experts convened
by the Food and Drug Administration on Tuesday overwhelmingly voted against
the use of MDMA, commonly known as ecstasy, to treat post-traumatic stress
disorder.

PTSD, a debilitating mental health condition that develops after a person
experiences or is threatened by traumatic events such as death, combat or
sexual assault, affects an estimated five percent of Americans in any given
year.

But pharmaceutical treatment options are so far limited to two
antidepressants that require three months of dosing to take effect, and
response rates to the medications have been found to be uneven.

California-based Lykos Therapeutics has based its request for regulatory
approval on two clinical studies, each of which enrolled around 100 people,
to evaluate MDMA used together with other psychological interventions such as
talk therapy, against a placebo with talk therapy.

These two studies, published in the prestigious journal Nature Medicine,
indicated MDMA was indeed both safe and highly effective at treating PTSD.

But nine out of 11 experts on the panel said available data was not enough to
show the treatment was effective, and 10 out of 11 said the benefits did not
outweigh the risks.

"I think this is a really exciting treatment. I'm really encouraged by the
results to date," said one of the experts, Paul Holtzheimer of the National
Center for PTSD.

"But I feel that both from an efficacy and a safety standpoint, it is still
premature."

The vote by the panel of experts is non-binding, but the FDA rarely goes
against their recommendations.

- Not enough side effect data -

MDMA -- methylenedioxymethamphetamine -- is a Schedule 1 drug under the
Controlled Substances Act, and approving it for medical use would have
represented a major shift.

In a briefing document put together ahead of the meeting, FDA staff raised
concerns that although the studies were nominally "double-blinded" -- meaning
neither those being tested nor their health care workers knew who received
the treatment versus the placebo -- most people were able to accurately guess
what they received.

This "functional unblinding," they argued, introduces bias and uncertainty
into study outcomes.

FDA staff also criticized Lykos for not gathering sufficient side effect
data, including whether participants experienced "euphoria" or "elated mood,"
which, they argued, "would be informative for an assessment of abuse
potential or characterization of anticipated effects of the drug."

Reports from recreational use suggest MDMA has harmful impacts on heart and
liver health -- but the company did not gather enough data in these areas,
the FDA said.

- Research misconduct allegations -

Then there were troubling allegations of research impropriety linked to the
trials that surfaced in a draft report by the nonprofit Institute for
Clinical and Economic Review.

These include claims that the trials "pulled heavily from the existing
community of those interested and involved in the use of psychedelics for
possible psychological benefits."

Some patients told the nonprofit they were allegedly prevented from entering
the long term-follow up study "and felt this was done to keep these negative
outcomes out of the data set."

"We certainly take those allegations very seriously and are quite concerned
by them," the FDA's Tiffany Farchione said during the meeting, adding a probe
was ongoing.

Lykos has said a final decision from the FDA on authorization should come by
mid-August.

If the agency were to authorize the treatment over the advisory panel's
objections, there could be certain strict stipulations attached -- for
example, that the drug only be dispensed in health care settings, with
subjects carefully monitored and enrolled in a registry to document side
effects.